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Intravenous Milk Thistle Compound

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Dr. Todd Mitchell with a pair of poisonous death cap mushrooms. Mitchell has treated several people who have eaten the toxic fungus.

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The call that awakened Dr. Todd Mitchell on the Tuesday after Christmas gave him chills.

A woman and her twin 11-year-old grandsons had eaten soup made from deadly mushrooms they picked in the woods. Dr. Kent Olson of California Poison Control was on the line, asking how to contact the German company that makes a drug used to treat death cap mushroom cases in Europe.

Mitchell knew mortality from death caps is higher for children.

He felt a sense of urgency, and the situation was hauntingly familiar.

Two years ago at Dominican Hospital in Santa Cruz, Mitchell and Dr. Wendy Knapp treated a family of six who had eaten tacos made of death cap mushrooms they picked at Wilder Ranch State Park.

Mitchell searched Google and found a treatment used in Europe, an intravenous milk thistle preparation called Legalon-Sil. He persuaded the Food and Drug Administration to allow its use as an emergency investigational new drug. He arranged for an air courier to deliver the medication to the San Francisco hospital where four of the six patients had been taken after developing liver failure and needed transplants.

None of the patients underwent transplants. All recovered but one, the 83-year-old grandmother. Her liver recovered but she succumbed to kidney failure.

Afterward, Mitchell prepared a report on the treatment for the FDA and made a presentation at a European toxicology conference in Seville, Spain.

Now, he
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was being asked whether he could retrace his steps, procure the intravenous milk thistle, obtain FDA approval and get it to San Francisco the very next day.

"It was like déjà vu all over," Mitchell said.

This time, the patients included Sarah Elbert, 72, a retired history professor and lifelong mushroom hunter from Ithaca, N.Y. While visiting her grandsons in the Bay Area, she had taken them mushroom picking on Mount Tamalpais in Marin County the Sunday after Christmas, and made soup.

Twelve hours later, all three were vomiting and experiencing diarrhea. Twice they went to the hospital and were discharged.

When the symptoms worsened, the family returned to the hospital, where they were told to drive to University of California-San Francisco Medical Center, which has a pediatric liver transplant unit.

Mitchell called Joe Veilleux of German drugmaker Madaus in Pittsburgh. Veilleux told him Madaus' offices in Germany were closed for the holiday and wouldn't reopen until Jan. 5. The same was true for an Italian company that bought Madaus six months after the Santa Cruz mushroom poison case.

"He told me I don't know what you will do,' " Mitchell said, so he called the FDA.

There is not a huge market for the drug in the United States because mushroom poisoning is more common in Europe. So the astronomical cost to get FDA approval for milk thistle extract, or silybinin, has so far stalled any effort to stock it in the United States for emergency use.

When Mitchell rang the FDA, he asked whether he could use the identification number granted two years ago for Legalon, which would speed things up. He was told he would have to reapply for permission.

Mitchell called the pharmacy at a hospital in Munich and asked for as much silybinin as it had in stock. Nicola Clausius, clinical pharmacist, said she would try to get the drug onto the next Lufthansa flight to San Francisco, departing Frankfurt the next morning. She arranged for a personal courier. As she packed the drug in a box, she asked whether Mitchell had the investigational new drug number the shipment required.

He didn't — yet.

Within hours of his call, the FDA phoned Mitchell. Staffers had met the Santa Cruz doctor and had seen the report he submitted the year before and decided to issue the requisite number.

Then the Munich pharmacist called with bad news. The first plane departing Frankfurt was sold out. The next flight would depart four hours later and arrive in San Francisco as rush hour traffic began.

Mitchell worried the special delivery would arrive too late for the twins, who were sicker than their grandmother. So he went to work explaining to Lufthansa why the stakes were high. After 15 minutes, he got a seat for the courier on the earliest flight.

But when the drug arrived — with expenses paid for by Madaus — there were only 14 vials rather than the 18 Mitchell had expected. Who would get what?

Doctors decided to treat the twins first because of the higher mortality rate in children.

By the next morning, both boys improved, allowing what remained of the drug to be given to their grandmother. She recovered and was discharged three days later. Her grandsons left the hospital eight days after ingesting the poison.

Another transglobal success story — that maybe next time won't be so hectic.

"I'm getting strong signals from the FDA that they may soon grant an open IND (investigational new drug) application for Legalon-Sil," Mitchell said Friday. "This would allow the antidote to be rapidly accessible from a California pharmacy after an amatoxin poisoning."

I think it's been known for some time that mil thistle if effective in treating mushroom poisoning. Most of the information comes from Germany where herbals are regulated and studied. Unfortunately, there hasn't been any evidence that mt is helpful with HCV. All studies so far have been negative.

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